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Patent Extension at Spectrum Pharma

The US Patent and Trademark Office (:USPTO) recently extended the patent covering Spectrum Pharmaceuticals’ (SPPI) Fusilev (levoleucovorin) for injection by more than two years. US patent no. 6,500,829, covering Fusilev for injection, was extended from the original date of Dec 31, 2019 to Mar 7, 2022.

Fusilev is approved in combination with chemotherapy with 5-fluorouracil as a palliative treatment for patients suffering from advanced metastatic colorectal cancer. The product is also marketed to rescue patients suffering from osteosarcoma following high-dose methotrexate therapy. Moreover, the drug is available to reduce the toxicity and combat the effects of impaired methotrexate elimination and of unintentional over dosage of folic acid antagonists.

In ex-US territories, the product is marketed by Pfizer Inc. (PFE) and Sanofi (SNY) among others, under various trade names.

We remind investors that Fusilev is the major contributor to Spectrum Pharma’s net product revenues. In the third quarter of 2012 Fusilev revenues came in at $52 million, representing 79% of the company’s net product sales.

We are impressed to see that Fusilev for injection patent was extended by two years. But we remain concerned about the competitive scenario in the metastatic colorectal cancer market.

We are also impressed with the company’s effort to increase the sales potential of Fusilev. In Nov 2012, the US Food & Drug Administration (:FDA) approved an additional manufacturing facility to produce Fusilev for injection. Spectrum Pharma has been increasing its number of qualified third-party manufacturing sites since the approval of the product in 2011.